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. 2022 May 20;6(6):e724. doi: 10.1097/HS9.0000000000000724

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Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Hematology Association.

This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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Figure 4. — Average percentage of assays from 5 IVD categories used by respondents of the questionnaire (n = 150), per diagnostic field. (1) CE-IVDs used strictly according to the manufacturer’s IFU; (2) CE-IVDs with minor modifications; (3) Off-label CE-IVDs; (4) RUO kits; and (5) In-house devices (IH-IVDs)/LDTs. A detailed explanation of the 5 IVD categories can be can be found in the main text and the report on the BioMed Alliance website.²⁷ CE-IVDs = CE marked in vitro diagnostics; IFU = instructions for use; IH-IVDs = in-house in vitro diagnostics; IVD = in vitro diagnostic; LDT = laboratory-developed test; RUO = Research Use Only.